Skin, Lip and Body Care

New Sunscreen Regulations-What You Need to Know

+ Rebecca

Are you protected from UVA rays?

They are the ones that are thought to be mostly responsible for causing skin cancer. And unless you’re a careful shopper, you may not be adequately protected.

For years, most sunscreens protected mainly from UVB rays-those that cause sunburn. Only those labeled as “broad-spectrum” sunscreens protected against both, and depending on the ingredients in the formula, at varying levels of effectiveness.

(Zinc oxide and titanium dioxide are the safest options and protect against both, but many sunscreen formulas do not use them because they can leave a visible white film.)

In June 2011, the FDA released new regulations to require manufacturers to provide customers with more information about their sunscreens. These new requirements went into effect between 2012-2013.

Because of these regulations, we now know more about what we’re buying. At the same time, however, the administration is dragging its feet on approving new sunscreen ingredients already in use in Europe-ingredients that may perform better than the ones already approved for use here in the U.S.

FDA Requires More from Sunscreen Manufacturers

To be in compliance with the new regulations, sunscreens must now pass the FDA’s test to show they protect against both UVA and UVB rays. Only those that do will be allowed to label their products as providing “broad-spectrum” protection.

Products with an SPF of 2-14 can be labeled as broad spectrum if they pass the test. Those with an SPF of 15 or higher and pass the test may be labeled as helping to reduce the risk of skin cancer and early skin aging.

Those that don’t pass the test and have an SPF of 2-14 now have to have a warning stating they do not help prevent cancer or skin aging.

Additional changes included:

  • Products can no longer claim to be waterproof-only water-resistant
  • Labels must state when the product becomes ineffective-after 40 or 80 minutes

The FDA was also considering banning products listing an SPF higher than 50, but they haven’t done that yet. SPF protection is believed to top out at 30-50.

What the FDA Regulations Do Not Tell You

While these new requirements were an improvement, we still have a long way to go. Today’s sunscreen labels still don’t tell us if the product has nanoparticles, which have been found to be damaging to the environment, and which can also penetrate skin to potentially cause free radical damage.

Labels also don’t specify which products are more effective. Just because a product has a high SPF and says it offers broad-spectrum protection doesn’t mean it’s the best product to use. Those that contain retinyl palmitate, for example-a form of vitamin A-may actually cause damage to skin. A 2012 study by the National Toxicology Program, for example, found that mice treated with small doses of retinyl palmitate who were then exposed to UV rays developed skin tumors faster than mice who weren’t treated with the retinyl palmitate.

We need more studies to determine how the ingredient may affect humans, but the study results were concerning, and consumers should be aware of when their sunscreens contain retinyl palmitate.

FDA Dragging Its Feet on New Sunscreen Ingredients

The most common so-called “chemical sunscreen” approved for use in the U.S. is avobenzone. (Read more about chemical sunscreens here.) According to the Environmental Working Group, however, four sunscreen ingredients currently in use in European countries “appear to be more effective than avobenzone,” but the FDA has failed to approve them.

These other ingredients have been on the market in Europe for many years-more than a decade in some cases-with no apparent safety issues. These ingredients are also known to provide wider spectrum protection against both types of UV rays, and are said to last longer on the skin, protecting those who forget to reapply. (Isn’t that most of us?)

The FDA has asked for additional data on these ingredients, but has yet to approve any. Because of the delays, in November 2014, Congress passed the “Sunscreen Innovation Act,” which was meant to speed up the approval process for these sunscreen ingredients, but so far the FDA has not been satisfied that these new ingredients are safe enough for U.S. customers. They have asked the companies that make them to supply more data that proves safety and efficacy.

What You Need to Do to Stay Protected

Is the FDA being overly cautious? Some people think so. Theresa M. Michele, director of FDA’s Division of Nonprescription Drug Products, isn’t one of them. She stated on the FDA website that the information they’ve received on these drugs so far doesn’t indicate whether long-term use is safe, how much is absorbed into the skin, or how the products may affect pregnant women.

Part of the issue is that in the U.S., sunscreens are regulated as drugs, whereas in Europe, they are considered cosmetics, and are associated with less red tape.

It’s good for the FDA to be cautious. The problem is that in the meantime, U.S. consumers are left with very few options if they want effective, broad-spectrum protection.

That means to really protect your skin, you should:

  • Make sure your sunscreen contains zinc oxide or titanium oxide for true broad-spectrum protection. (The EWG also recommends avobenzone-I prefer to avoid it because it’s more of a “chemical sunscreen.”)
  • Buy products with an SPF of 30 or more. (Realize that products labeled as having an SPF over 50 don’t offer greater protection.)
  • Use lotions, not sprays. The FDA has asked for more data on sprays, because they may not deposit enough sunscreen on the skin, and may also be inhaled into the lungs.
  • Remember that sunscreen does not make you invincible-avoid peak sun times between 10:00 a.m. and 3:00 p.m., and use hats, clothing, and umbrellas.
  • Avoid products that contain retinyl palmitate or other derivatives.
  • Avoid chemical sunscreens, particularly those with oxybenzone, which is a hormone disruptor.
  • Look for fragrance-free products to avoid exposure to excessive chemicals.

Are you more careful with your sunscreen purchases? Please share any tips you may have.

“NTP Technical Report on the Photocarcinogenesis Study of Retinoic Acid and Retinyl Palmitate,” National Toxicology Program, August 2012,

“Does Europe Have Better Sunscreens?” EWG,

“Sunscreen Innovation Act,”

Roni Caryn Rabin, “The New Rules for Sunscreen,” New York Times, May 27, 2013,

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